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New hope for Tough-to-Treat lymphoma: experimental drug shows promise

NCT ID NCT04703192

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study tests an experimental drug called valemetostat in people with a rare type of blood cancer (peripheral T-cell lymphoma) that has returned or not responded to prior treatments. The goal is to see if the drug can shrink tumors and how safe it is. About 155 adults will take the drug as a pill, and researchers will monitor their response and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

155 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Written informed consent * Participants ≥18 years of age or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed. * Eastern Cooperative Oncology Group performance status of 0, 1, or 2 * Cohort 1 relapsed/refractory peripheral T-cell lymphoma (PTCL): * Diagnosis should be confirmed by the local pathologist; local histological diagnosis will be used for eligibility determination. Participants with the following subtypes of PTCL are eligible according to 2016 WHO classification prior to the initiation of study drug. Any T-cell lymphoid malignancies not listed are excluded. Eligible subtypes include: * Enteropathy-associated T-cell lymphoma * Monomorphic epitheliotropic intestinal T-cell lymphoma * Hepatosplenic T-cell lymphoma * Primary cutaneous γδ T-cell lymphoma * Primary cutaneous CD8+ aggressive epidermotropic cytotoxic T-cell lymphoma * PTCL, not otherwise specified * Angioimmunoblastic T-cell lymphoma * Follicular T-cell lymphoma * Nodal PTCL with T-follicular helper (TFH) phenotype * Anaplastic large cell lymphoma, ALK positive * Anaplastic large cell lymphoma, ALK negative * Cohort 2 relapsed/refractory adult T-cell leukemia/lymphoma (ATL) acute, lymphoma, or unfavorable chronic type. Relapsed/refractory ATL should be confirmed by the local pathologist; local diagnosis will be used for eligibility determination. The positivity of anti-human T-cell leukemia virus type 1 (HTLV-1) antibody will be locally determined for eligibility. * Must have at least one lesion which is measurable in 2 perpendicular dimensions on computed tomography (or magnetic resonance imaging) based on local radiological read * Documented refractory, relapsed, or progressive disease after at least 1 prior line of systemic therapy. * Refractory is defined as: * Failure to achieve CR (or CRu for ATL) after first-line therapy * Failure to reach at least PR after second-line therapy or beyond * Must have at least 1 prior line of systemic therapy for PTCL or ATL. * Participants must be considered hematopoietic cell transplantation (HCT) ineligible during screening due to disease status (active disease), comorbidities, or other factors; the reason for HCT ineligibility must be clearly documented. * In the PTCL cohort, participants with anaplastic large cell lymphoma (ALCL) must have prior brentuximab vedotin treatment. Exclusion Criteria: Participants meeting any exclusion criteria for this study will be excluded from this study. Below is a list of the key exclusion criteria: * Diagnosis of mycosis fungoides, Sézary syndrome and primary cutaneous ALCL, and systemic dissemination of primary cutaneous ALCL * Diagnosis of precursor T-cell leukemia and lymphoma (T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma), T-cell prolymphocytic leukemia, or T-cell large granular lymphocytic leukemia * Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered as cured, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer. * Presence of active central nervous system involvement of lymphoma * History of autologous HCT within 60 days prior to the first dose of study drug * History of allogeneic HCT within 90 days prior to the first dose of study drug * Clinically significant graft-versus-host disease (GVHD) or GVHD requiring systemic immunosuppressive prophylaxis or treatment * Inadequate washout period from prior lymphoma-directed therapy before enrollment, defined as follows: * Prior systemic therapy (eg, chemotherapy, immunomodulatory therapy, or monoclonal antibody therapy) within 3 weeks prior or 5 half-lives of the drug, whichever is longer, to the first dose of study drug * Had curative radiation therapy or major surgery within 4 weeks or palliative radiation therapy within 2 weeks prior to the first dose of study drug * Uncontrolled or significant cardiovascular disease, including: * Evidence of prolongation of QT/QTc interval (eg, repeated episodes of QT corrected for heart rate using Fridericia's method \>450 ms) (average of triplicate determinations) * Diagnosed or suspected long QT syndrome or known family history of long QT syndrome * History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes * Uncontrolled arrhythmia (subjects with asymptomatic, controllable atrial fibrillation may be enrolled) or asymptomatic persistent ventricular tachycardia * Participant has clinically relevant bradycardia of \<50 bpm, unless the participant has a pacemaker * History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers within 6 months prior to Screening * Myocardial infarction within 6 months prior to Screening * Angioplasty or stent craft implantation within 6 months prior to Screening * Uncontrolled angina pectoris within 6 months prior to Screening * New York Heart Association Class 3 or 4 congestive heart failure * Coronary/peripheral artery bypass graft within 6 months prior to Screening * Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) * Complete left bundle branch block * History of treatment with other EZH inhibitors * Current use of moderate or strong cytochrome P450 (CYP)3A inducers * Systemic treatment with corticosteroids (\>10 mg daily prednisone equivalents). Note: Short-course systemic corticosteroids (eg, prevention/treatment for transfusion reaction) or use for a non-cancer indication (eg, adrenal replacement) is permissible. * Known or suspected hypersensitivity to valemetostat tosylate or any of the excipients

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Conditions

The condition(s) this trial relates to.

adult T-cell leukemia/lymphoma mature T-cell and NK-cell non-Hodgkin lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult T-cell leukemia/lymphoma Relapsed/refractory peripheral T-cell lymphoma

Contacts and locations

Locations

  • A.O.di Bologna Policl.S.Orsola

    Bologna, 40138, Italy

  • APHP - Hopital Saint Louis

    Paris, 75010, France

  • ASST Papa Giovanni XXIII - Medicina Trasfusionale ed Ematologia - Bergamo

    Bergamo, 24127, Italy

  • Asan Medical Center - Oncology

    Seoul, 05505, South Korea

  • BC Cancer - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • CHRU de Lille - Hôpital Claude Huriez - Maladies du Sang

    Lille, 59037, France

  • CHU de Dijon

    Dijon, 21079, France

  • Centre Hospitalier Lyon Sud - Hématologie

    Pierre-Bénite, 69495, France

  • Centre Lyon Berard - Medical Oncology

    Lyon, 69008, France

  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology

    Kaohsiung City, 83301, Taiwan

  • Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology

    Taoyuan City, 33305, Taiwan

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • City Of Hope National Medical Center

    Duarte, California, 91010, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Emory University Hospital - Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Epworth Healthcare

    Richmond, 3121, Australia

  • Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori

    Naples, 80131, Italy

  • Hackensack University Medical Center - John Theurer Cancer Center

    Hackensack, New Jersey, 07601, United States

  • Hokkaido University Hospital - Medical Oncology Center

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hôpital Necker

    Paris, 75015, France

  • ICO Hospital Duran i Reynals

    Barcelona, 08029, Spain

  • Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole)

    Toulouse, 31100, France

  • Kagoshima University Hospital

    Kagoshima, 890-8520, Japan

  • Kyushu University Hospital

    Fukuoka, 812-0054, Japan

  • Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center)

    Leiden, 2333ZA, Netherlands

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55901, United States

  • Memorial Sloan-Kettering Cancer Center at Memorial Hospital

    New York, New York, 10065, United States

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital - Internal Medicine

    Tainan, 70403, Taiwan

  • National Hospital Organization Nagoya Medical Center - Hematology

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Taiwan University Hospital - Hematology And Oncology

    Taipei, 10002, Taiwan

  • Northwestern University - Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • Nottingham City Hospital - Clinical Haematology

    Nottingham, NG5 1PB, United Kingdom

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Ospedale S.Maria della Misericordia, AO di Perugia, Università degli Studi di Perugia

    Perugia, 06132, Italy

  • Ottawa Hospital Research Institute

    Ottawa, K1H 8L6, Canada

  • PO San Gerardo, ASST Monza

    Monza, 20900, Italy

  • Samsung Medical Center - Hematology-Oncology

    Seoul, 06351, South Korea

  • Seoul National University Hospital - Department of Internal

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Stanford University Medical Center - Cancer Clinical Trials Office - ONCOLOGY

    Palo Alto, California, 94304, United States

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591, South Korea

  • Universiteit Maastricht Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX, Netherlands

  • University College London Hospital

    London, NW1 2PG, United Kingdom

  • University Health Network Princess Margaret Hospital

    Toronto, M5G 1Z5, Canada

  • University Hospital - Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University Of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Pennsylvania Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Universitätsklinikum Halle (Saale) - Klinik und Poliklinik für Innere Medizin IV

    Halle, 06120, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

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Other studies related to the condition(s) this trial covers.